Pharmacokinetic Modeling of Methadone

NCT05490732 | Recruiting

• 1 other identifier: 21_0614
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The management of patients with opioid addiction is a challenge insofar as many distractors or variability factors can interfere with the control of the addiction, whether they are psychological, psychiatric, environmental, pharmacokinetic or pharmacodynamic. Understanding this variability is potentially to be able to adjust a priori a dosage and to identify the factors of clinical response. Few population pharmacokinetic models exist for methadone and they generally concern the management of pain in palliative care patients or the management of opioid withdrawal syndrome in neonates. The hypothesis is therefore that the creation of such a model would make it possible to reduce patients' withdrawal periods, to set a target for plasma concentrations with a view to reducing dosages, and to empower the patient in his choice to monitor blood concentrations facilitated by a minimally invasive sampling device.

Conditions

Toxicomania

Keywords

pharmacokinetics; methadone; microsampling; modeling

Outcome Measures

Primary Outcomes (1)

• Peak concentration (Cmax)

  To evaluate and estimate methadone/EDDP (metabolite) Cmax for patients treated for opioid addiction.

  18 months

Secondary Outcomes (2)

• C12h-24h concentration

  18 months

• Residual concentration (C0)

  18 months

Study Arms (1)

Therapeutic drug monitoring of methadone

EXPERIMENTAL

6 samplings per subject: 3 venipunctures and 3 microsamplings

Biological: Blood sampling

Interventions

Blood sampling BIOLOGICAL

Patient will be subjected to 3 blood sampling over 24hours. At H0, H4 and H12-24. For each one, one microsampling and one venipuncture

Also known as: Volumetric absorptive microsampling

Therapeutic drug monitoring of methadone

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major patients on methadone on the same dosage for at least 7 days.
• Hospitalization for withdrawal in the addictology department of La Colombière or consultation within the unit for the treatment of drug addiction and dependence (Addictology Department).
• hours monitoring is possible and accepted

You may not qualify if:

• Patients that cannot be sampled because of weakened veins
• Unable to received information about the study
• Adult protected by law or patient under guardianship
• Not affiliated to french social security system
• Not able to give written inform consent
• Pregnant or breastfeeding woman
• Underaged patients (under 18 years old)
• Patient under court protection

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yoann Cazaubon, phD,pharmD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoann Cazaubon, phD,pharmD

CONTACT

+33467336261; yoann.cazaubon@chu-montpellier.fr

Hélène Donnadieu-Rigole, phD,MD

CONTACT

+33467337811; h-donnadieu_rigole@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 8, 2022
• Study Start: March 23, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)